NCATS SBIR/STTR Small Business Programs

NCATS SBIR Phase II

Backs small businesses scaling proven translational findings into applied solutions and early market readiness.

The National Center for Advancing Translational Sciences (NCATS) administers SBIR Phase II grants (R44) to support expanded research, development, and early commercialization activities for small US businesses that have demonstrated feasibility in a Phase I award. NCATS's four priority topic areas — preclinical drug discovery and development, biomedical and health research informatics, clinical and dissemination and implementation research, and rare disease and unmet needs — define the scope of eligible work. Phase II is the major development grant in the NCATS small business pipeline, and the standard NIH SBIR Phase II budget is approximately $2 million (R44 mechanism).

Eligibility is limited to US-based small business concerns, majority US-owned and operated, that have completed a Phase I SBIR award or can demonstrate equivalent prior work. The STTR Phase II variant (R42) continues to require a formal research institution partnership. NCATS also provides a Phase IIB/III Bridge mechanism for companies advancing beyond standard Phase II toward commercialization; NCATS program staff pre-approval is required before submitting a Phase IIB/III Bridge application, and this track enables applicants to access additional support beyond the ~$2 million Phase II cap. Topics are reviewed biannually, and submission follows NIH parent FOA PA-25-303 or NCATS-specific RFA cycles.

Because NCATS underwent organizational restructuring in 2026 and NIH-wide FY2026 OMB appropriations withholding created fund-release uncertainty, applicants should contact NCATS-SBIRSTTR@mail.nih.gov well in advance of a target cycle to confirm topical fit, current FOA status, and available funding. Competitive Phase II applicants typically present strong Phase I outcome data, a well-defined path to commercialization or clinical adoption, and a clear description of how the proposed work advances one of NCATS's four translational science priority areas.